Clinical and Immunologic Studies of Semisynthetic Human Monocomponent Insulin (U-100) in Diabetic Children

Abstract

Thirty-five patients with insulin-dependent diabetes mellitus were treated with semisynthetic human monocomponent insulin (HMI) (Monotard and Actrapid insulin) for six months. The subjects were divided into two groups depending on the type of insulin treatment. Group A consisted of 15 patients who were treated with porcine monocomponent insulin (PMI) (Monotard and Actrapid insulin), and Group B consisted of 20 patients who were treated with conventional porcine-bovine insulin (U-100 Lento insulin) and PMI (Actrapid insulin). Daily insulin doses; duration of diabetes, and age at entry into this study were significantly higher in group B. Comparison of HMI and previous insulin treatments revealed the following results: 1) Increments of blood glucose, serum total insulin and free insulin after subcutaneous injection of HMI were not significantly different from the same doses and composition of PMI or U-100 Lento and porcine actrapid insulin. 2) Insulin-specific IgG antibody was significantly higher in group B than in group A. 3) Insulin-specific IgG antibody was significantly lowered during the six-month HMI treatment in both groups, especially in group B. 4) Daily insulin doses were not significantly changed in group A; however, they were significantly decreased in group B during the six-month HMI treatment. 5) Mean hemoglobin A1 levels were not significantly changed in groups A and B during the HMI treatment. 6) No adverse side effects were observed during the HMI tratment. It ws concluded that HMI (U-100) is safe and effective in the treatment of diabetic children and that a change from PMI to HMI does not require any special precautions. However, a change from U-100 Lento insulin to HMI requires special precautions to prevent the development of hypoglycemia in insulin-dependent diabetic children. © 1987, THE JAPAN DIABETES SOCIETY. All rights reserved.